Ranibizumab trial gets promising results for CNV
medwireNews: Patients with visual impairment due to myopic choroidal neovascularisation (CNV) achieve better visual acuity (VA) after 3 months of individualised treatment with ranibizumab than with verteporfin photodynamic therapy (vPDT), show the results of a phase III randomised controlled trial.
CNV is a common vision-threatening complication secondary to pathological myopia, explain the researchers, led by Sebastian Wolf (University of Bern, Switzerland). They add that until recently, vPDT was the only approved treatment, and while it has been shown to stabilise CNV, improvements in vision are “uncommon”.
Since vascular endothelial growth factor (VEGF)-A is known to play a role in the development of myopic CNV, the team randomly assigned 277 patients with CNV to three treatment groups in the RADIANCE (Ranibizumab And PDT [verteporfIn] evAluation iN myopic Choroidal nEovascularization) study, to investigate the effects of the VEGF-A inhibitor ranibizumab.
Group 1 (n=106) received ranibizumab 0.5 mg injection on day 1 of month 1 of the trial and thereafter as needed according to VA stabilisation criteria. Group 2 (n=116) received the same treatment regimen, but guided by disease activity criteria, with discontinuation in the absence of visual impairment. Group 3 (n=55) received an intravenous dose of vPDT 6 mg/m2 on day 1 and ranibizumab for disease activity after month 3 of the trial, at the researchers' discretion.
They found that best-corrected (BC)VA was significantly better after 3 months of treatment in groups 1 and 2 compared with group 3, with an average 10.5 and 10.6 Early Treatment Diabetic Retinopathy Study (ETDRS) letters gained, respectively, versus 2.2.
Furthermore, the dosing regimen had no significant effect on outcome. Specifically, treating with ranibizumab according to VA stabilisation (no change in BCVA for 2 preceding months) was not superior after 6 months compared with treatment according to disease activity (visual impairment attributable to intraretinal or subretinal fluid or active leakage secondary to myopic CNV), with an average of 11.9 and 11.7 ETDRS letters gained, respectively.
Patients in group 3 who went on to receive ranibizumab after month 3 showed gradual improvements between that point and month 12 of the study, report Wolf et al, who suggest this could indicate that “it is important to initiate ranibizumab early in patients with myopic CNV”.
Finally, ocular and nonocular adverse events were reported by around 44% of patients across the groups and included conjunctival haemorrhage and nasopharyngitis. Instances of serious ocular and nonocular adverse events were low, at 0.7%, 4.0% and 0.0% for groups 1, 2 and 3, respectively, indicating that both ranibizumab and vPDT are well tolerated.
RADIANCE provides “robust clinical evidence for the efficacy and safety of ranibizumab in patients with myopic CNV”, the researchers therefore conclude.
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By Sarah Pritchard, medwireNews Reporter